Mirikizumab Real World Protocol

NCT06696014 | Recruiting

• 1 other identifier: 24-2191
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 9

Brief Summary

The goal of this observational study is to learn about how effective mirikizumab (Omvoh) is when treating patients with ulcerative colitis (UC) Does mirikizumab (Omvoh) lead to a reduction in symptoms at intervals throughout one year? Participants being prescribed mirikizumab (Omvoh) as part of their regular medical care for UC will answer online survey questions about their bowel habits for 1 year.

Conditions

Ulcerative Colitis

Keywords

mirikizumab; Omvoh; MIRROR

Outcome Measures

Primary Outcomes (1)

• induction of clinical response as evaluated by the Simple Clinical Colitis Activity Index (SCCAI) for the patient-reported outcomes.

  The SCCAI is a 6-item that describes the symptoms and disease activity of a patient with UC at the time of assessment. A score of 0-4 is considered a clinical range of remission (but with more refined definitions of clinical remission with SCCAI ≤2 and very mild symptoms with a score \>2 ≤4), 5-7 mild activity, 8-16 moderate activity and \> 16 severe activity. A response will be defined as a decrease of the SCCAI score \< 5 points in patients with a baseline SCCAI ≥5.

  Weeks 1,2,4,8,12,18,24,36, and 52 after the start of therapy (each time point will be assessed separately)

Secondary Outcomes (7)

• Remission as measured by Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression Scoreoint will be assessed separately) (as measured by various PROs as outlined in methods)

  Weeks 0, 12, 24, and 52.

• Remission as measured by PROMIS-Anxiety Score

  Weeks 0, 12, 24, and 52

• Remission as measured by PROMIS-Sleep Score

  Weeks 0, 12, 24, and 52

• Remission as measured by PROMIS-Social Satisfaction Score

  Weeks 0, 12, 24, and 52

• Remission as measured by Likert scale urgency Score

  Weeks 1,2,4,8,12,18,24,36, and 52 after the start of therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with ulcerative colitis starting mirikizumab in the setting of standard-of-care

You may qualify if:

• Adult patients, age 18 years or older, with UC, who within 2 weeks have been started on mirikizumab therapy for moderate to severe UC or who plan to begin this therapy within the next 2 weeks. The start of the mirikizumab treatment must have been or be initiated in the setting of standard-of-care therapy.
• Anticipation that the patient will be followed by the participating center for the next 12 months.
• Diagnosis of UC must be established based on standard clinical, radiographic, endoscopic, and histologic criteria as described below.
• Criteria for diagnosis of UC The following diagnostic criteria were developed by the NIDDK IBD Genetics Consortium and are provided as guidelines to complete documentation on individuals with Ulcerative Colitis.
• A) Symptoms including one or more: diarrhea, rectal bleeding, abdominal pain, fever, extraintestinal manifestations, weight loss, or failure to thrive.
• AND
• B) Symptoms on two or more occasions separated by at least 8 weeks or ongoing symptoms of at least 6 weeks duration.
• AND
• C) Endoscopic Findings compatible with UC:
• Superficial inflammation and/or ulceration (involving only the mucosa and submucosa) of the colon, which is continuous from the rectum extending proximally without skip lesions or complete rectal sparing (relative rectal sparing is allowed for patients receiving topical, rectal therapy; patchiness of endoscopic inflammation may be observed in patients with partially treated ulcerative colitis).
• In patients with proctitis or left-sided ulcerative colitis, there may be an area of inflammation in the cecum, usually surrounding the appendiceal orifice.
• No inflammation of the small intestine ("backwash ileitis" is allowed - non-stenotic superficial inflammation of the terminal ileal mucosa associated with severe pancolitis, which resolves following medical or surgical treatment of the colitis).

You may not qualify if:

• Patients will be excluded if they meet any of the following criteria:
• Inability to provide informed consent.
• Non-English speaking.
• Patients presenting for a one-time consultation.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Eli Lilly and Company: collaborator

Study Sites (9)

South Denver Gastroenterology

Denver, Colorado, 80113, United States

RECRUITING

AdventHealth

Orlando, Florida, 32804, United States

RECRUITING

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

RECRUITING

University of Louisville, Clinical Trials Unit

Louisville, Kentucky, 40202, United States

RECRUITING

University Of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

RECRUITING

Southern Star Research Institute, LLC

San Antonio, Texas, 78229, United States

RECRUITING

TIDHI Innovation Inc.

Toronto, Ontario, M6A3B4, Canada

RECRUITING

Related Publications (16)

• Dubinsky M, Bleakman AP, Panaccione R, Hibi T, Schreiber S, Rubin D, Dignass A, Redondo I, Gibble TH, Kayhan C, Travis S. Bowel Urgency in Ulcerative Colitis: Current Perspectives and Future Directions. Am J Gastroenterol. 2023 Nov 1;118(11):1940-1953. doi: 10.14309/ajg.0000000000002404. Epub 2023 Jun 12.

  PMID: 37436151 RESULT

• Singh S, Ananthakrishnan AN, Nguyen NH, Cohen BL, Velayos FS, Weiss JM, Sultan S, Siddique SM, Adler J, Chachu KA; AGA Clinical Guidelines Committee. Electronic address: clinicalpractice@gastro.org. AGA Clinical Practice Guideline on the Role of Biomarkers for the Management of Ulcerative Colitis. Gastroenterology. 2023 Mar;164(3):344-372. doi: 10.1053/j.gastro.2022.12.007.

  PMID: 36822736 RESULT

• Higgins PD, Schwartz M, Mapili J, Krokos I, Leung J, Zimmermann EM. Patient defined dichotomous end points for remission and clinical improvement in ulcerative colitis. Gut. 2005 Jun;54(6):782-8. doi: 10.1136/gut.2004.056358.

  PMID: 15888785 RESULT

• Barnes EL, Hanson JS, Regueiro MD, Saha S, Sands BE, Rubin DT, Dubinsky MC, Siegel CA, Gazis DR, Crawford JM, Long MD. Older Adult Patients Use More Aminosalicylate Monotherapy Compared With Younger Patients With Inflammatory Bowel Disease: TARGET-IBD. J Clin Gastroenterol. 2022 Jul 1;56(6):529-535. doi: 10.1097/MCG.0000000000001557. Epub 2021 Jun 11.

  PMID: 34115661 RESULT

• Tinsley A, Macklin EA, Korzenik JR, Sands BE. Validation of the functional assessment of chronic illness therapy-fatigue (FACIT-F) in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2011 Dec;34(11-12):1328-36. doi: 10.1111/j.1365-2036.2011.04871.x. Epub 2011 Oct 17.

  PMID: 21999576 RESULT

• Dubinsky MC, Clemow DB, Hunter Gibble T, Li X, Vermeire S, Hisamatsu T, Travis SPL. Clinical Effect of Mirikizumab Treatment on Bowel Urgency in Patients with Moderately to Severely Active Ulcerative Colitis and the Clinical Relevance of Bowel Urgency Improvement for Disease Remission. Crohns Colitis 360. 2022 Dec 13;5(1):otac044. doi: 10.1093/crocol/otac044. eCollection 2023 Jan.

  PMID: 36777368 RESULT

• Outtier A, Gijbels L, Noman M, Verstockt B, Sabino J, Vermeire S, Ferrante M. Screening Failure in a Large Clinical Trial Centre for Inflammatory Bowel Diseases: Rates, Causes, and Outcomes. Inflamm Bowel Dis. 2023 Sep 1;29(9):1440-1445. doi: 10.1093/ibd/izac227.

  PMID: 36350998 RESULT

• Bewtra M, Brensinger CM, Tomov VT, Hoang TB, Sokach CE, Siegel CA, Lewis JD. An optimized patient-reported ulcerative colitis disease activity measure derived from the Mayo score and the simple clinical colitis activity index. Inflamm Bowel Dis. 2014 Jun;20(6):1070-8. doi: 10.1097/MIB.0000000000000053.

  PMID: 24810138 RESULT

• Long MD, Afzali A, Fischer M, Hudesman D, Abdalla M, McCabe R, Cohen BL, Ungaro RC, Harlan W, Hanson J, Konijeti G, Polyak S, Ritter T, Salzberg B, Seminerio J, English E, Zhang X, Sharma PP, Herfarth HH. Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting. Inflamm Bowel Dis. 2023 Apr 3;29(4):570-578. doi: 10.1093/ibd/izac121.

  PMID: 35700276 RESULT

• Ha C, Ullman TA, Siegel CA, Kornbluth A. Patients enrolled in randomized controlled trials do not represent the inflammatory bowel disease patient population. Clin Gastroenterol Hepatol. 2012 Sep;10(9):1002-7; quiz e78. doi: 10.1016/j.cgh.2012.02.004. Epub 2012 Feb 15.

  PMID: 22343692 RESULT

• Dulai PS, Singh S, Jairath V, Wong E, Narula N. Integrating Evidence to Guide Use of Biologics and Small Molecules for Inflammatory Bowel Diseases. Gastroenterology. 2024 Mar;166(3):396-408.e2. doi: 10.1053/j.gastro.2023.10.033. Epub 2023 Nov 8.

  PMID: 37949249 RESULT

• Lichtenstein GR, Yan S, Bala M, Hanauer S. Remission in patients with Crohn's disease is associated with improvement in employment and quality of life and a decrease in hospitalizations and surgeries. Am J Gastroenterol. 2004 Jan;99(1):91-6. doi: 10.1046/j.1572-0241.2003.04010.x.

  PMID: 14687148 RESULT

• Ananthakrishnan AN, Weber LR, Knox JF, Skaros S, Emmons J, Lundeen S, Issa M, Otterson MF, Binion DG. Permanent work disability in Crohn's disease. Am J Gastroenterol. 2008 Jan;103(1):154-61. doi: 10.1111/j.1572-0241.2007.01561.x. Epub 2007 Dec 11.

  PMID: 18076736 RESULT

• Shivashankar R, Tremaine WJ, Harmsen WS, Loftus EV Jr. Incidence and Prevalence of Crohn's Disease and Ulcerative Colitis in Olmsted County, Minnesota From 1970 Through 2010. Clin Gastroenterol Hepatol. 2017 Jun;15(6):857-863. doi: 10.1016/j.cgh.2016.10.039. Epub 2016 Nov 14.

  PMID: 27856364 RESULT

• Herrinton LJ, Liu L, Lewis JD, Griffin PM, Allison J. Incidence and prevalence of inflammatory bowel disease in a Northern California managed care organization, 1996-2002. Am J Gastroenterol. 2008 Aug;103(8):1998-2006. doi: 10.1111/j.1572-0241.2008.01960.x.

  PMID: 18796097 RESULT

• Loftus EV Jr, Schoenfeld P, Sandborn WJ. The epidemiology and natural history of Crohn's disease in population-based patient cohorts from North America: a systematic review. Aliment Pharmacol Ther. 2002 Jan;16(1):51-60. doi: 10.1046/j.1365-2036.2002.01140.x.

  PMID: 11856078 RESULT

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Hans Herfarth, MD, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily English, MSW, CCRC

CONTACT

919-843-8105; emily_english@med.unc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 52 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 19, 2024
• Study Start: May 8, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

CA (1); US (8)